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FDA 510(k)

SERODOT TOXOPLASMA IGG TEST KIT

K-Number: K875363 · 1988-04-21

ApplicantDisease Detection International, Inc.
Decision Date1988-04-21
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERODOT TOXOPLASMA IGG TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Disease Detection International, Inc.. It received FDA 510(k) clearance on 1988-04-21 under 510(k) number K875363. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERODOT TOXOPLASMA IGG TEST KIT?

SERODOT TOXOPLASMA IGG TEST KIT is a medical device that received FDA 510(k) clearance on 1988-04-21. The listed applicant is Disease Detection International, Inc.. The 510(k) number is K875363.

When did SERODOT TOXOPLASMA IGG TEST KIT receive FDA 510(k) clearance?

SERODOT TOXOPLASMA IGG TEST KIT received FDA 510(k) clearance on 1988-04-21, under 510(k) number K875363.

Who is the listed applicant for SERODOT TOXOPLASMA IGG TEST KIT?

The FDA 510(k) record lists Disease Detection International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERODOT TOXOPLASMA IGG TEST KIT?

The FDA product code for SERODOT TOXOPLASMA IGG TEST KIT is LGD.

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Related Devices (Code: LGD)

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K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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